Systems, methods, and devices for performing electronically controlled test stimulation

ABSTRACT

The present disclosure involves systems and methods of programming electrical stimulation therapy for a patient. A communications link is established with a pulse generator that is configured to generate electrical stimulation pulses. An intermittent electrical coupling between the pulse generator and a diagnostic tool is simulated. This simulation is performed by instructing, for a plurality of cycles, the pulse generator to automatically turn on and off the generation of electrical stimulation pulses. Each cycle includes a first time period and a second time period following the first time period. The simulating includes: instructing the pulse generator to generate the electrical stimulation pulses during the first time period; and instructing the pulse generator to stop generating the electrical stimulation pulses during the second time period.

PRIORITY DATA

The present application is a utility application of provisional U.S.Patent Application No. 62/173,118, filed on Jun. 9, 2015, entitled“ADVANCED METHODS AND APPARATUSES FOR PERFORMING PELVIC NERVESTIMULATION,” and a utility application of provisional U.S. PatentApplication No. 62/181,827, filed on Jun. 19, 2015, entitled “ADVANCEDMETHODS AND APPARATUSES FOR PERFORMING PELVIC NERVE STIMULATION,” thedisclosures of each which are hereby incorporated by reference in theirrespective entireties.

BACKGROUND

The invention relates to a stimulation system, such as a pelvic nerve orsacral nerve stimulation system, having a tool for programming anelectrical stimulation generator, such as an implantable pulse generator(IPG), of the system.

A sacral nerve stimulator is a device used to provide electricalstimulation to the pelvic region of a patient, for example the sacralnerve or the pudendal nerve, in order to treat problems such asincontinence. The stimulator includes an implanted or external pulsegenerator and an implanted stimulation lead having one or moreelectrodes at a distal location thereof. The pulse generator providesthe stimulation through the electrodes via a body portion and connectorof the lead. Stimulation programming in general refers to theconfiguring of stimulation electrodes and stimulation parameters totreat the patient using one or more implanted leads and its attachedIPG. For example, the programming is typically achieved by selectingindividual electrodes and adjusting the stimulation parameters, such asthe shape of the stimulation waveform, amplitude of current in mA (oramplitude of voltage in V), pulse width in microseconds, frequency inHz, and anodic or cathodic stimulation.

Despite recent advances in medical technology, existing sacral nervestimulation methods, systems, and devices still have variousshortcomings. For example, in order to determine the efficacy ofstimulation and the implant site for an implantable pulse generator,test stimulation may be applied to a patient via an external trialstimulator. Conventional systems and methods for performing teststimulation have been cumbersome and may require a lot of manualinvolvement from the clinician, thereby leading to potentiallyineffective test stimulation or other mistakes/errors. Therefore,although existing systems and methods for performing sacral nervestimulation are generally adequate for their intended purposes, theyhave not been entirely satisfactory in all respects.

SUMMARY

One aspect of the present disclosure involves a portable electronicdevice for programming electrical stimulation therapy for a patient. Theportable electronic device includes a graphical user interfaceconfigured to receive an input from a user and communicate an output tothe user; an electronic memory storage configured to store programminginstructions; and one or more processors configured to execute theprogramming instructions to perform the following steps: establishing acommunications link with a pulse generator that is configured togenerate electrical stimulation pulses; and simulating an intermittentelectrical coupling between the pulse generator and a diagnostic tool byinstructing the pulse generator to automatically turn on and off thegeneration of electrical stimulation pulses for a plurality of cycles;wherein: each cycle includes a first time period and a second timeperiod following the first time period; the simulating comprisesinstructing the pulse generator to generate the electrical stimulationpulses during the first time period; and the simulating furthercomprises instructing the pulse generator to stop generating theelectrical stimulation pulses during the second time period.

Another aspect of the present disclosure involves a medical system. Themedical system includes: a pulse generator configured to generateelectrical stimulation pulses as a part of an electrical stimulationtherapy for a patient; a diagnostic tool configured to be insertedpercutaneously inside the body of the patient to deliver the electricalstimulation pulses; and a portable electronic device that is coupled tothe pulse generator through a communications link, wherein the portableelectronic device is configured to simulate an intermittent electricalcoupling between the pulse generator and the diagnostic tool by sendinginstructions to the pulse generator to turn on and off the generation ofelectrical stimulation pulses for a plurality of cycles; wherein: eachcycle includes a first time period and a second time period followingthe first time period; the portable electronic device instructs thepulse generator to generate the electrical stimulation pulses during thefirst time period; and the portable electronic device instructs thepulse generator to stop generating the electrical stimulation pulsesduring the second time period.

Yet another aspect of the present disclosure involves a method ofprogramming electrical stimulation therapy for a patient. The methodincludes: establishing a communications link with a pulse generator thatis configured to generate electrical stimulation pulses; and simulatingan intermittent electrical coupling between the pulse generator and adiagnostic tool by instructing, for a plurality of cycles, the pulsegenerator to automatically turn on and off the generation of electricalstimulation pulses, wherein each cycle includes a first time period anda second time period following the first time period, and wherein thesimulating includes: instructing the pulse generator to generate theelectrical stimulation pulses during the first time period; andinstructing the pulse generator to stop generating the electricalstimulation pulses during the second time period.

BRIEF DESCRIPTION OF THE DRAWINGS

Aspects of the present disclosure are best understood from the followingdetailed description when read with the accompanying figures. It isemphasized that, in accordance with the standard practice in theindustry, various features are not drawn to scale. In fact, thedimensions of the various features may be arbitrarily increased orreduced for clarity of discussion. In the figures, elements having thesame designation have the same or similar functions.

FIG. 1 is stylized overview of the human nervous system.

FIG. 2A is a diagram illustrating an example sacral implantation of aneurostimulation lead according to various embodiments of the presentdisclosure.

FIG. 2B is a simplified diagram illustrating an implantableneurostimulation system for stimulating nerves according to variousembodiments of the present disclosure.

FIGS. 3A-3B illustrate an example pocket programmer controller inaccordance with one embodiment of the present disclosure.

FIG. 4 is a block diagram of components of the example pocket controllerof FIGS. 3A-3B in accordance with one embodiment of the presentdisclosure.

FIGS. 5A-5B illustrate an example patient programmer charger controllerin accordance with one embodiment of the present disclosure.

FIG. 6 is a block diagram of components of the example patientprogrammer charger of FIGS. 5A-5B in accordance with one embodiment ofthe present disclosure.

FIG. 7 is a block diagram of a clinician programmer according to oneembodiment of the present disclosure.

FIG. 8 is a block diagram of an implantable pulse generator according toone embodiment of the present disclosure.

FIG. 9 is a diagrammatic block diagram of a patient feedback deviceaccording to an embodiment of the present disclosure.

FIGS. 10A and 10B are exterior views of the patient feedback deviceaccording to embodiments of the present disclosure.

FIG. 11A is a side view of a patient-feedback device inserted in themouth of a patient according to an embodiment of the present disclosure.

FIG. 11B is a side view of a patient-feedback device with opticalsensing according to an embodiment of the present disclosure.

FIG. 11C is a side view of a patient-feedback device activated by a footof a patient according to an embodiment of the present disclosure.

FIG. 12 is a simplified block diagram of a medical system/infrastructureaccording to various aspects of the present disclosure.

FIG. 13 illustrates a medical system for performing test stimulationaccording to various aspects of the present disclosure.

FIGS. 14-16 illustrate a graphical user interface for performingelectronically controlled test stimulation according to various aspectsof the present disclosure.

FIG. 17 is a waveform illustrating an intermittent electrical couplingbetween a pulse generator and a diagnostic tool under the control of anelectronic programmer according to various aspects of the presentdisclosure.

FIG. 18 is a flowchart illustrating a method of mimicking anintermittent electrical connection between a pulse generator and adiagnostic tool as a part of programming electrical stimulation therapyfor a patient.

DETAILED DESCRIPTION

It is to be understood that the following disclosure provides manydifferent embodiments, or examples, for implementing different featuresof the invention. Specific examples of components and arrangements aredescribed below to simplify the present disclosure. These are, ofcourse, merely examples and are not intended to be limiting. Variousfeatures may be arbitrarily drawn in different scales for simplicity andclarity.

Before any embodiments of the invention are explained in detail, it isto be understood that the invention is not limited in its application tothe details of construction and the arrangement of components set forthin the following description or illustrated in the following drawings.The invention is capable of other embodiments and of being practiced orof being carried out in various ways.

The human nervous system includes a complex network of neurologicalstructures that extend throughout the body. As shown in FIG. 1, thebrain interconnects with the spinal cord which branches into thebrachial plexus near the shoulders and the lumbar plexus and sacralplexus in the lower back. The limb peripheral nerves of the arms extenddistally from the brachial plexus down each arm. Similarly, the limbperipheral nerves of the legs extend distally from the lumbar plexus andsacral plexus. A number of the larger limb peripheral nerves areidentified in FIG. 1. As discussed further below, certain aspects of thepresent invention are particularly well suited to stimulation of thepudendal nerves and the sacral nerves, including those identified inFIG. 1.

FIG. 2A is a simplified diagram illustrating implantation of aneurostimulation lead 10. In the example of FIG. 2A, lead 10 is insertedinto body 12 of a patient, and implanted posterior to one of dorsalforamen 14 of sacrum 16. However, lead 10 alternatively may bepositioned to stimulate pudendal nerves, perineal nerves, sacral spinalnerves, or other areas of the nervous system. Lead 10 may be implantedvia a needle and stylet for minimal invasiveness. Positioning of lead 10may be aided by imaging techniques, such as fluoroscopy. In someembodiments, a plurality of stimulation leads may be provided.

FIG. 2B is a diagram illustrating an implantable neurostimulation system19 for stimulating a nerve, such as a sacral nerve, via the lead 10.Neurostimulation system 19 delivers neurostimulation to the sacralnerves or other regions of the nervous system known to treat problemsincluding, but are not limited to: pelvic floor disorders, urinarycontrol disorders, fecal control disorders, interstitial cystitis,sexual dysfunction, and pelvic pain. As shown in FIG. 2B, system 19includes lead 10 and an implantable pulse generator (IPG). In addition,a proximal end of stimulation lead 10 may be coupled to a connectorblock 21 associated with the neurostimulator 20.

In some embodiments, the neurostimulator 20 includes an implantablepulse generator (IPG), and delivers neurostimulation therapy to patient12 in the form of electrical pulses generated by the IPG. In the exampleof FIG. 2B, the neurostimulator 20 is implanted in the upper leftbuttock of patient 12, but it is understood that the neurostimulator 20be implanted at other locations in alternative embodiments.

The lead 10 carries one or more of stimulation electrodes, e.g., 1 to 8electrodes, to permit delivery of electrical stimulation to the targetnerve, such as the sacral nerve. For example, the implantableneurostimulation system 19 may stimulate organs involved in urinary,fecal or sexual function via C-fibers or sacral nerves at the second,third, and fourth sacral nerve positions, commonly referred to as S2,S3, and S4, respectively. In some embodiments, the neurostimulator 20may be coupled to two or more leads deployed at different positions,e.g., relative to the spinal cord or sacral nerves.

The implantable neurostimulation system 19 also may include a clinicianprogrammer 22 and a patient programmer 23. The clinician programmer 22may be a handheld computing device that permits a clinician to programneurostimulation therapy for patient 12, e.g., using input keys and adisplay. For example, using clinician programmer 22, the clinician mayspecify neurostimulation parameters for use in delivery ofneurostimulation therapy. The clinician programmer 22 supports radiofrequency telemetry with neurostimulator 20 to download neurostimulationparameters and, optionally, upload operational or physiological datastored by the neurostimulator. In this manner, the clinician mayperiodically interrogate neurostimulator 20 to evaluate efficacy and, ifnecessary, modifies the stimulation parameters.

Similar to clinician programmer 22, patient programmer 23 may be ahandheld computing device. The patient programmer 23 may also include adisplay and input keys to allow patient 12 to interact with patientprogrammer 23 and implantable neuro stimulator 20. In this manner, thepatient programmer 23 provides the patient 12 with an interface forcontrol of neurostimulation therapy by neurostimulator 20. For example,the patient 12 may use patient programmer 23 to start, stop or adjustneurostimulation therapy. In particular, the patient programmer 23 maypermit the patient 12 to adjust stimulation parameters such as duration,amplitude, pulse width and pulse rate, within an adjustment rangespecified by the clinician via the clinician programmer 22.

The neurostimulator 20, clinician programmer 22, and patient programmer23 may communicate via wireless communication, as shown in FIG. 2B. Theclinician programmer 22 and patient programmer 23 may, for example,communicate via wireless communication with neurostimulator 20 using RFtelemetry techniques known in the art. The clinician programmer 22 andpatient programmer 23 also may communicate with each other using any ofa variety of local wireless communication techniques, such as RFcommunication according to the 802.11 or Bluetooth specification sets,or other standard or proprietary telemetry protocols. It is alsounderstood that although FIG. 2B illustrates the patient programmer 22and the clinician programmer 23 as two separate devices, they may beintegrated into a single programmer in some embodiments.

The various aspects of the present disclosure will now be discussed inmore detail below.

FIGS. 3A-3B, 4, 5A-5B, and 6 illustrate various example embodiments ofthe patient pocket programmer 22 (hereinafter referred to as patientprogrammer for simplicity) according to various aspects of the presentdisclosure. In more detail, FIGS. 3A-3B, 4 are directed to a patientprogrammer that is implemented as a pocket controller 104, and FIGS.5A-5B and 6 are directed to a patient programmer that is implemented asa patient programmer charger (PPC) 106.

Referring now to FIGS. 3A and 3B, the pocket controller 104 comprises anouter housing 120 having an on-off switch 122, a user interfacecomprising a plurality of control buttons 124, and a display 126. Inthis embodiment, the housing 120 is sized for discreetness and may besized to fit easily in a pocket and may be about the same size as a keyfob. In one example, the housing 120 forming the pocket controller 104has a thickness of less than about 1.5 inch, a width of less than about1.5 inch, and a height of less than about 3 inches. In another example,the housing 120 forming the pocket controller 104 has a thickness ofabout 0.8 inch, a width of about 1.4 inch, and a height of about 2.56inch. However, both larger and smaller sizes are contemplated.

In this example, the control buttons 124 include two adjustment buttons128 a, 128 b, a select button 130, and an emergency off button (notshown, but disposed on a side of the housing 120 opposing the on-offswitch 122). The two adjustment buttons 128 a, 128 b allow a user toscroll or highlight available options and increase or decrease valuesshown on the display 126. The select button 130 allows a user to enterthe value or select the highlighted options to be adjusted by actuationof the adjustment buttons 128 a, 128 b. In this example, the buttons 128a, 128 b are used to navigate to one of the three availablefunctions: 1) electrical stimulation on/off, 2) control stimulationamplitude adjustment, and 3) electrical stimulation program selection.Once the desired function is highlighted, the select button is pushed toallow changes (i.e. change the stimulation amplitude, select a differentstimulation program, or turn the electrical stimulation on or off). Insome examples, the IPG control functions of the pocket controller 104consist of these functions. The emergency off button is disposed foreasy access for a patient to turn off stimulation from the IPG 102 ifthe IPG provides too much stimulation or stimulation becomesuncomfortable for the patient. Allowing the user to scroll through theplurality of options (also referred to herein as operational parameters)that can be adjusted via the pocket controller 104 provides the user theconfidence to carry only the pocket controller 104 while away from home.Users may be reluctant to carry only a conventional controller thatallows adjustment of only a single operational parameter out of fearthat they may need to adjust a different operational parameter whileaway from a more full-featured controller.

In the embodiment shown, the display 126 is an LCD display arranged toconvey information to the user regarding selectable options, presentsettings, operating parameters and other information about the IPG 102or the pocket controller 104. In this example, the display 126 shows thepocket controller's battery status at 132, the IPG's battery status at134, the IPG's on or off status at 136, the currently selectedelectrical stimulation program at 138, and the amplitude setting of therunning electrical stimulation program at 140. Other types of displaysare also contemplated.

FIG. 4 shows a block diagram of components making up the pocketcontroller 104. It includes a user interface 150, a control module 152,a communication module 154, and a power storing controller 156. The userinterface 150 is comprised of the buttons 128 a, 128 b, 130 and thedisplay 126 described above with reference to FIG. 3A.

As can be seen, the user interface 150 is in communication with thecontrol module 152. The control module 152 comprises a processor 158,memory, an analog-digital converter 162, and a watch dog circuit 164.The processor 158 may include a microprocessor, a controller, a digitalsignal processor (DSP), an application specific integrated circuit(ASIC), a field programmable gate array (FPGA), discrete logiccircuitry, or the like. The processor 158 is configured to execute codeor instructions provided in the memory. Here, the memory is comprised offlash memory 166 and RAM memory 168. However, the memory may include anyvolatile or non-volatile media, such as a random access memory (RAM),read only memory (ROM), non-volatile RAM (NVRAM), electrically erasableprogrammable ROM (EEPROM), flash memory, and the like. In someembodiments, the memory stores sets of stimulation control parametersthat are available to be selected for delivery through the communicationmodule 154 to the IPG 102 for electrical stimulation therapy. The ADconverter 162 performs known functions of converting signals and the WD164 is arranged to time out when necessary, such as in an event wherethe software becomes stuck in a loop. In one embodiment, the controlmodule 152 comprises integrated circuits disposed on a PC board.

The communication module 154 comprises a medical implant communicationservice (MICS) RF transceiver 172 used to communicate with the IPG 102to communicate desired changes and to receive status updates from andrelating to the IPG 102, such as battery status and any errorinformation. As used herein, MICS refers to wireless communications in afrequency band ranging from about 402 MHz to about 405 MHz, which isdedicated for communications with implanted medical devices. In thisexample, the MICS RF transceiver 172 utilizes a loop antenna for thecommunications with the IPG 102. Other antennas, such as, for example,dipole, chip antennas, or other known in the art also may be used. Thecommunication module 154 also includes a wake up transmitter 174, anamplifier 176, and matching networks 178. The wake up transmitter 174operates on a high frequency and is configured to send a short signalburst to wake up the IPG 102 when it is in a power-saving mode. Once theIPG 102 is ready, a communications link can be established between theIPG 102 and pocket controller 104, and communications can then occurover the MICS transceiver 172 using a standard frequency for a medicaldevice transmission. The matching networks 178 tunes the antenna foroptimum transmission power for the frequency selected. The pocketcontroller 104 also includes a programming interface 182. This may beused during manufacturing to load an operating system and program thepocket controller 104.

The power storing controller 156 is configured to convert power torecharge one or more rechargeable batteries 180. The batteries 180provide power to operate the pocket controller 104 allowing it toreceive user inputs and transmit control signals to the IPG 102. Someembodiments use primary cell batteries instead of rechargeablebatteries. As indicated above, this pocket controller 104 is part of alarger system that contains the PPC 106 with a rich feature set forcontrolling the IPG 102 and includes an integrated battery charger usedto charge the IPG's battery. By providing both the pocket controller 104and the PPC 106, the patient can have a small unobtrusive device tocarry around as they go about their daily business and a larger morefull featured device which they can use in the comfort and privacy oftheir homes.

The pocket controller 104 is not only comfortable to carry in a pocket,but can also be attached to a key ring, lanyard, or other such carryingdevice for ease of daily use. Its functions are a subset of functionsfound on the PPC 106, and permit a user to power stimulation from theIPG on and off (i.e., the IPG 102 remains on, but stimulation is toggledbetween the on state when the IPG 102 is emitting electrical pulses andthe off state when the IPG 102 is not emitting electrical pulses butremains in the standby mode for additional communications from thepocket controller 104, the PPC 106, or both), select which electricalstimulation program to run, and globally adjust the amplitude ofelectrical pulses emitted in a series of electrical pulses emitted bythe IPG 102. By limiting the functions of the pocket controller to thosemost commonly used on a daily basis, the device becomes much lessintimidating to the patient, and allows it to be kept very small. Bykeeping the device small, such as about key fob size, it becomesunobtrusive and the patient is more comfortable with having and using animplanted device.

FIGS. 5A-5B show the PPC 106 in greater detail. FIG. 5A is a front viewof the PPC and FIG. 5B is a top view of FIG. 5A. The PPC 106 performsall the same operating functions as the pocket controller 104, butincludes additional operating functions making it a multi-functionfull-featured, advanced patient controller charger. In the embodimentshown, the PPC 106 provides a simple but rich feature set to the moreadvanced user, along with the charging functions.

The PPC 106 includes a controller-charger portion 200 and a coil portion202 connected by a flexible cable 204 and sharing components asdescribed below. The controller-charger portion 200 comprises an outerhousing 206 having an on-off switch 208 on its side, a plurality ofcontrol buttons 210, and a display 212, and an emergency off button (notshown, but disposed on a side of the housing 206 opposing the on-offswitch 208). In this embodiment, the control buttons 210 are icons onthe display 212, and the display is a full color, touch screen,graphical user interface. In addition, the controller-charger portion200 includes a home button 214 configured to return the displayed imagesto a home screen. The controller-charger portion 200 is larger than thepocket controller 104 and in one embodiment is sized with a heightgreater than about 3 inches, a width greater than about 2.5 inches, anda thickness greater than about 0.8 inch. In another embodiment, thecontroller-charger portion is sized with a width of about 3.1 inches, aheight of about 4.5 inches, and thickness of about 0.96 inches, althoughboth larger and smaller sizes are contemplated.

In this example, the control buttons 210 allow a user to select adesired feature for control or further display. Particularly, thecontrol buttons 210 enable functions of the PPC 106 that are the same asthose of the pocket controller 104 (stimulation on/off, programstimulation amplitude adjustment, and stimulation program selection)along with additional features including: charging IPG battery,individual pulse stimulation amplitude adjustment that adjusts anamplitude of an individual pulse relative to the amplitude of anadjacent pulse in a series of pulses emitted by the IPG 102, stimulationprogram frequency adjustment, individual pulse width adjustment,detailed IPG status, detailed PPC status, PPC setup/configuration, a PPCbattery status indicator, PPC to IPG communication status indicator, andother items and functions. The detailed IPG status may include, forexample, IPG serial number and IPG software revision level. Detailed PPCstatus may include, for example, date and time setting, brightnesscontrol, audio volume and mute control, and PPC serial number andsoftware revision level.

By having a pocket controller 104 that is limited to a plurality, suchas only three controls (stimulation on/off, program amplitude adjust,and stimulation program selection), for example, a user can quickly andeasily identify and select the features that are most commonly used.Features that are used less frequently, such as IPG recharge, areincluded on the full-featured PPC, but not the pocket controller 104.Features that are seldom accessed, or not accessed at all by some users,including individual pulse amplitude adjust, pulse width adjust,stimulation program frequency adjust, or serial number and softwarerevision information, are also not included on the limited-featurepocket controller, but are included on the PPC. This allows the pocketcontroller to be significantly smaller, with a very simple and easy touser interface, as compared to systems that need to support all of thesefeatures.

Referring to the example shown in FIG. 5A, the touch screen display 212is arranged to convey information to the user regarding selectableoptions, current settings, operating parameters and other informationabout the IPG 102 or the PPC 106. In this example, the display 212 showsa MICS communication indicator 220, the PPC's battery status at 222, theIPG's battery status at 224, the IPG's on or off status at 226, thecurrently selected electrical stimulation program at 228, and theamplitude setting of the active electrical stimulation program at 230.In addition, the display 212 shows the frequency 232, the pulse widthsetting 234, a selectable status icon for accessing detailed PPCinformation 236, a selectable status icon for accessing detailed IPGinformation 238, and a selectable icon for enabling IPG charging 240.Selecting any single icon may activate another menu within that selectedsubject area. The controller-charger portion 200 may include arechargeable battery whose charge status is shown by the PPC's batterystatus at 222.

The coil portion 202 is configured to wirelessly charge the batteries inthe IPG 102. In use, the coil portion 202 is applied against thepatient's skin or clothing externally so that energy can be inductivelytransmitted and stored in the IPG battery. As noted above, the coilportion 202 is connected with the integrated controller-charger portion200. Accordingly, the controller-charger portion 200 can simultaneouslydisplay the current status of the coil portion 204, the battery powerlevel of the IPG 102, as well as the battery power level of the PPC.Accordingly, controlling and charging can occur in a more simplistic,time-effective manner, where the patient can perform all IPG maintenancein a single sitting. In addition, since the most commonly used featuresof the PPC 106 are already functional on the pocket controller, the PPC106 may be left at home when the user does not desire to carry thelarger, more bulky PPC.

FIG. 6 shows a block diagram of the components making up the PPC 106. Itincludes a user interface 250, a control module 252, a communicationmodule 254, an IPG power charging module 256, and a power storing module258. The user interface 250 is comprised of the buttons 210 and thedisplay 212 described above. In this embodiment however, the userinterface 250 also includes one or more LEDs 266 signifying whether thePPC 106 is charging or powered on and a backlight 268 that illuminatesthe color display. In some embodiments, these LEDs may have colorssymbolizing the occurring function. An LED driver 270 and a speaker oramplifier 272 also form a part of the user interface 250.

As can be seen, the user interface 250 is in communication with thecontrol module 252. The control module 252 comprises a processor 276,memory 278, and a power management integrated circuit (PMIC)/real timeclock (RTC) 280. In the example shown, the control module 252 alsoincludes a Wi-Fi RF transceiver 282 that allows the PPC 106 to connectto a wireless network for data transfer. For example, it may permitdoctor-patient interaction via the internet, remote access to PPC logfiles, remote diagnostics, and other information transfer functions. ThePMIC 280 is configured to control the charging aspects of the PPC 106.The Wi-Fi transceiver 282 enables Wi-Fi data transfer for programmingthe PPC 106, and may permit wireless access to stored data and operatingparameters. Some embodiments also include a Bluetooth RF transceiver forcommunication with, for example, a Bluetooth enabled printer, akeyboard, etc.

In one embodiment, the control module 252 also includes an AD converterand a watch dog circuit as described above with reference to the controlmodule 252. Here, the memory 278 is comprised of flash memory and RAMmemory, but may be other memory as described above. In some embodiments,the processor 276 is an embedded processor running a WinCE operatingsystem (or any real time OS) with the graphics interface 250, and thememory 278 stores sets of stimulation control parameters that areavailable to be selected for delivery through the communication module254 to the IPG 102 for electrical stimulation therapy. In oneembodiment, the control module 252 comprises integrated circuitsdisposed on a PC board.

The communication module 254 comprises a MICS RF transceiver 290, a wakeup transmitter 292, an amplifier 294, and matching networks 296. Thecommunication module 254 may be similar to the communication module 154discussed above, and will not be further described here. The PPC 206also includes a programming interface 298 that may be used duringmanufacturing to load an operating system and program the PPC 206.

The power storing module 258 is configured to convert power to rechargeone or more rechargeable batteries 302. In this embodiment, thebatteries 302 are lithium-ion cells that provide power to operate thePPC 106 allowing it to receive user inputs, transmit control signals to,and charge the IPG 102. The power storing module 258 includes aconnector 304 for connecting to a power source, a power protectiondetection circuit 306 for protecting the PPC from power surges, andlinear power supplies 308 for assisting with the electric transfer tocharge the batteries 302. As can be seen, the control module 252 aidswith the charging and is configured to monitor and send the batterycharge level to the user interface 250 for display. The connector 304connects the PPC, directly or indirectly, to a power source (not shown)such as a conventional wall outlet for receiving electrical current. Insome embodiments, the connector 304 comprises a cradle.

The power charging module 256 communicates with the control module 252and is arranged to magnetically or inductively charge the IPG 102. Inthe embodiments shown, it is magnetically or inductively coupled to theIPG 102 to charge rechargeable batteries on the IPG 102. The chargingmodule 256 includes components in both the controller-charger portion200 and the coil portion 202 (FIGS. 5A-5B). It includes switch boostcircuitry 316, a load power monitor 318, an LSK demodulator 321, a ASKmodulator 322, a current mode transmitter 324, an ADC 326, and coils328. As can be seen, the control module 252 aids with the charging andis configured to monitor and send the IPG battery charge level to theuser interface 250 for display.

In this embodiment, the coils 328 are disposed in the coil portion 202and are configured to create magnetic or inductive coupling withcomponents in the IPG 102. Since the coil portion 202 is integrated withthe controller-charger portion 200, both operate from a single battery302. Accordingly, as can be seen by the circuitry, the battery 302powers the control module 252 and all its associated components. Inaddition, the battery 302 powers the power charging module 256 forrecharging the IPG 102.

Because the coil portion 202 is integrated with the controller-chargerportion 200, the control module 252 provides a single control interfaceand a single user interface for performing both functions of controllingthe IPG 102 and of charging the IPG 102. In addition, because thecontroller-charger portion 200 and the coil portion 202 are integrated,the controller-charger portion 200 simultaneously controls both thecurrent status of the charger, the battery power level of the IPG 102,as well as the battery power level of the PPC. Accordingly, controllingand charging can occur in a more simplistic, time-effective manner,where the patient can perform all IPG maintenance in a single sitting.In addition, since the most commonly used features of the PPC 106 arealready functional on the pocket controller, the PPC 106 may be left athome when the user does not desire to carry the larger, more bulky PPC.

FIG. 7 shows a block diagram of one example embodiment of a clinicianprogrammer (CP), for example the CP 22 shown in FIG. 2B. The CP 22includes a printed circuit board (“PCB”) that is populated with aplurality of electrical and electronic components that provide power,operational control, and protection to the CP 22. With reference to FIG.7, the CP includes a processor 300. The processor 300 is a controllerfor controlling the CP 22 and, indirectly, the IPG 20 as discussedfurther below. In one construction, the processor 300 is an applicationsprocessor model i.MX515 available from Freescale Semiconductor. Morespecifically, the i.MX515 applications processor has internalinstruction and data cashes, multimedia capabilities, external memoryinterfacing, and interfacing flexibility. Further information regardingthe i.MX515 applications processor can be found in, for example, the“IMX510EC, Rev. 4” data sheet; dated August 2010; published by FreescaleSemiconductor at www.freescale.com, the content of the data sheet beingincorporated herein by reference. Of course, other processing units,such as other microprocessors, microcontrollers, digital signalprocessors, etc., can be used in place of the processor 300.

The CP 22 includes memory, which can be internal to the processor 300(e.g., memory 305), external to the processor 300 (e.g., memory 310), ora combination of both. Exemplary memory include a read-only memory(“ROM”), a random access memory (“RAM”), an electrically erasableprogrammable read-only memory (“EEPROM”), a flash memory, a hard disk,or another suitable magnetic, optical, physical, or electronic memorydevice. The processor 300 executes software that is capable of beingstored in the RAM (e.g., during execution), the ROM (e.g., on agenerally permanent basis), or another non-transitory computer readablemedium such as another memory or a disc. The CP 22 also includesinput/output (“I/O”) systems that include routines for transferringinformation between components within the processor 300 and othercomponents of the CP 22 or external to the CP 22.

Software included in the implementation of the CP 22 is stored in thememory 305 of the processor 300, memory 310 (e.g., RAM or ROM), orexternal to the CP 22. The software includes, for example, firmware, oneor more applications, program data, one or more program modules, andother executable instructions. The processor 300 is configured toretrieve from memory and execute, among other things, instructionsrelated to the control processes and methods described below for the CP22. For example, the processor 300 is configured to execute instructionsretrieved from the memory 140 for establishing a protocol to control theIPG 20.

One memory shown in FIG. 7 is memory 310, which can be a double datarate (DDR2) synchronous dynamic random access memory (SDRAM) for storingdata relating to and captured during the operation of the CP 22. Inaddition, a secure digital (SD) multimedia card (MMC) can be coupled tothe CP for transferring data from the CP to the memory card via slot315. Of course, other types of data storage devices can be used in placeof the data storage devices shown in FIG. 7.

The CP 22 includes multiple bi-directional radio communicationcapabilities. Specific wireless portions included with the CP 22 are aMedical Implant Communication Service (MICS) bi-direction radiocommunication portion 320, a WiFi bi-direction radio communicationportion 325, and a Bluetooth bi-direction radio communication portion330. The MICS portion 320 includes a MICS communication interface, anantenna switch, and a related antenna, all of which allows wirelesscommunication using the MICS specification. The WiFi portion 325 andBluetooth portion 330 include a WiFi communication interface, aBluetooth communication interface, an antenna switch, and a relatedantenna all of which allows wireless communication following the WiFiAlliance standard and Bluetooth Special Interest Group standard. Ofcourse, other wireless local area network (WLAN) standards and wirelesspersonal area networks (WPAN) standards can be used with the CP 22.

The CP 22 includes three hard buttons: a “home” button 335 for returningthe CP to a home screen for the device, a “quick off” button 340 forquickly deactivating stimulation IPG, and a “reset” button 345 forrebooting the CP 22. The CP 22 also includes an “ON/OFF” switch 350,which is part of the power generation and management block (discussedbelow).

The CP 22 includes multiple communication portions for wiredcommunication. Exemplary circuitry and ports for receiving a wiredconnector include a portion and related port for supporting universalserial bus (USB) connectivity 355, including a Type-A port and a Micro-Bport; a portion and related port for supporting Joint Test Action Group(JTAG) connectivity 360, and a portion and related port for supportinguniversal asynchronous receiver/transmitter (UART) connectivity 365. Ofcourse, other wired communication standards and connectivity can be usedwith or in place of the types shown in FIG. 7.

Another device connectable to the CP 22, and therefore supported by theCP 22, is an external display. The connection to the external displaycan be made via a micro High-Definition Multimedia Interface (HDMI) 370,which provides a compact audio/video interface for transmittinguncompressed digital data to the external display. The use of the HDMIconnection 370 allows the CP 22 to transmit video (and audio)communication to an external display. This may be beneficial insituations where others (e.g., the surgeon) may want to view theinformation being viewed by the healthcare professional. The surgeontypically has no visual access to the CP 22 in the operating room unlessan external screen is provided. The HDMI connection 370 allows thesurgeon to view information from the CP 22, thereby allowing greatercommunication between the clinician and the surgeon. For a specificexample, the HDMI connection 370 can broadcast a high definitiontelevision signal that allows the surgeon to view the same informationthat is shown on the LCD (discussed below) of the CP 22.

The CP 22 includes a touch screen I/O device 375 for providing a userinterface with the clinician. The touch screen display 375 can be aliquid crystal display (LCD) having a resistive, capacitive, or similartouch-screen technology. It is envisioned that multitouch capabilitiescan be used with the touch screen display 375 depending on the type oftechnology used.

The CP 22 includes a camera 380 allowing the device to take pictures orvideo. The resulting image files can be used to document a procedure oran aspect of the procedure. For example, the camera 380 can be used totake pictures of barcodes associated with the IPG 20 or the leads 120,or documenting an aspect of the procedure, such as the positioning ofthe leads. Similarly, it is envisioned that the CP 22 can communicatewith a fluoroscope or similar device to provide further documentation ofthe procedure. Other devices can be coupled to the CP 22 to providefurther information, such as scanners or RFID detection. Similarly, theCP 22 includes an audio portion 385 having an audio codec circuit, audiopower amplifier, and related speaker for providing audio communicationto the user, such as the clinician or the surgeon.

The CP 22 further includes a power generation and management block 390.The power generation and management block 390 has a power source (e.g.,a lithium-ion battery) and a power supply for providing multiple powervoltages to the processor, LCD touch screen, and peripherals.

FIG. 8 shows a block diagram of an example embodiment of an IPG, forexample an embodiment of the IPG 20 shown in FIG. 2B. The IPG 20includes a printed circuit board (“PCB”) that is populated with aplurality of electrical and electronic components that provide power,operational control, and protection to the IPG 20. With reference toFIG. 8, the IPG 20 includes a communication portion 400 having atransceiver 405, a matching network 410, and antenna 412. Thecommunication portion 400 receives power from a power ASIC (discussedbelow), and communicates information to/from the microcontroller 415 anda device (e.g., the CP 22) external to the IPG 20. For example, the IPG20 can provide bi-direction radio communication capabilities, includingMedical Implant Communication Service (MICS) bi-direction radiocommunication following the MICS specification.

The IPG 20, as previously discussed, provides stimuli to electrodes 150of an implanted medical electrical lead 110. As shown in FIG. 8, Nelectrodes 150 are connected to the IPG 20. In addition, the enclosureor housing 420 of the IPG 20 can act as an electrode. The stimuli areprovided by a stimulation portion 425 in response to commands from themicrocontroller 415. The stimulation portion 425 includes a stimulationapplication specific integrated circuit (ASIC) 430 and circuitryincluding blocking capacitors and an over-voltage protection circuit. Asis well known, an ASIC is an integrated circuit customized for aparticular use, rather than for general purpose use. ASICs often includeprocessors, memory blocks including ROM, RAM, EEPROM, Flash, etc. Thestimulation ASIC 430 can include a processor, memory, and firmware forstoring preset pulses and protocols that can be selected via themicrocontroller 415. The providing of the pulses to the electrodes 150is controlled through the use of a waveform generator and amplitudemultiplier of the stimulation ASIC 430, and the blocking capacitors andovervoltage protection circuitry of the stimulation portion 425, as isknown in the art. The stimulation portion 425 of the IPG 20 receivespower from the power ASIC (discussed below). The stimulation ASIC 430also provides signals to the microcontroller 415. More specifically, thestimulation ASIC 430 can provide impedance values for the channelsassociated with the electrodes 150, and also communicate calibrationinformation with the microcontroller 415 during calibration of the IPG20.

The IPG 20 also includes a power supply portion 440. The power supplyportion includes a rechargeable battery 445, fuse 450, power ASIC 455,recharge coil 460, rectifier 463 and data modulation circuit 465. Therechargeable battery 445 provides a power source for the power supplyportion 440. The recharge coil 460 receives a wireless signal from thePPC 135. The wireless signal includes an energy that is converted andconditioned to a power signal by the rectifier 463. The power signal isprovided to the rechargeable battery 445 via the power ASIC 455. Thepower ASIC 455 manages the power for the IPG 20. The power ASIC 455provides one or more voltages to the other electrical and electroniccircuits of the IPG 155. The data modulation circuit 465 controls thecharging process.

The IPG also includes a magnetic sensor 480. The magnetic sensor 480provides a “hard” switch upon sensing a magnet for a defined period. Thesignal from the magnetic sensor 480 can provide an override for the IPG20 if a fault is occurring with the IPG 20 and is not responding toother controllers. The magnetic sensor 480 can also be used to turn onand off stimulation.

The IPG 20 is shown in FIG. 8 as having a microcontroller 415. Generallyspeaking, the microcontroller 415 is a controller for controlling theIPG 20. The microcontroller 415 includes a suitable programmable portion481 (e.g., a microprocessor or a digital signal processor), a memory482, and a bus or other communication lines. An exemplarymicrocontroller capable of being used with the IPG is a model MSP430ultra-low power, mixed signal processor by Texas Instruments. Morespecifically, the MSP430 mixed signal processor has internal RAM andflash memories, an internal clock, and peripheral interfacecapabilities. Further information regarding the MSP 430 mixed signalprocessor can be found in, for example, the “MSP430G2x32, MSP430G2x02MIXED SIGNAL MICROCONTROLLER” data sheet; dated December 2010, publishedby Texas Instruments at www.ti.com; the content of the data sheet beingincorporated herein by reference.

The IPG 20 includes memory, which can be internal to the control device(such as memory 482), external to the control device (such as serialmemory 495), or a combination of both. Exemplary memory include aread-only memory (“ROM”), a random access memory (“RAM”), anelectrically erasable programmable read-only memory (“EEPROM”), a flashmemory, a hard disk, or another suitable magnetic, optical, physical, orelectronic memory device. The programmable portion 481 executes softwarethat is capable of being stored in the RAM (e.g., during execution), theROM (e.g., on a generally permanent basis), or another non-transitorycomputer readable medium such as another memory or a disc.

Software included in the implementation of the IPG 20 is stored in thememory 482. The software includes, for example, firmware, one or moreapplications, program data, one or more program modules, and otherexecutable instructions. The programmable portion 481 is configured toretrieve from memory and execute, among other things, instructionsrelated to the control processes and methods described below for the IPG20. For example, the programmable portion 481 is configured to executeinstructions retrieved from the memory 482 for sweeping the electrodesin response to a signal from the CP 22.

The PCB also includes a plurality of additional passive and activecomponents such as resistors, capacitors, inductors, integratedcircuits, and amplifiers. These components are arranged and connected toprovide a plurality of electrical functions to the PCB including, amongother things, filtering, signal conditioning, or voltage regulation, asis commonly known.

FIG. 9 is a block diagram of an exemplary handheld patient feedbackdevice or patient feedback tool (hereinafter interchangeably referred toas PFD or PFT) 500 for use in a neurostimulation system, and FIGS. 10Aand 10B are diagrammatic illustrations of the PFT 500 according tovarious example embodiments. With reference to FIGS. 9 and 10A-10B, thePFT 500 includes a housing 502 which may have one or more of a sensor, acontroller, and/or a communication port connected thereto. Theconstruction of the PFT 500 shown in FIG. 9 includes two inputs 504 and505 in communication with the housing 502 of the device 500 and oneinput 510 internal to the housing 502. One of the external inputs 504 isa binary ON/OFF switch, for example activated by the patient's thumb, toallow the patient to immediately deactivate stimulation. Input 504 maybe coupled to the controller 525 via electrostatic discharge (ESD)protection and/or debouncing circuits. The second input 505 includes aforce sensor sensing the pressure or force exerted by the patient'shand. Input/sensor 505 may be coupled to the controller 525 via ESDprotection, signal conditioning, and/or signal amplification circuits.The sensed parameter can be either isotonic (constant force, measuringthe distance traversed) or isometric (measured force, proportional topressure applied by patient). The resulting signal from the sensor 505is analog and, therefore, after the signal is conditioned and/oramplified, it can be passed to microcontroller 525 via ananalog-to-digital converter.

The internal input 510 for the PFT 500 may be a motion sensor. Thesensor 510, upon detecting motion, initiates activation of the PFT 500.The device 500 stays active until movement is not detected by the sensor510 for a time period, which in various constructions may be between onesecond and five minutes. Power is provided by an internal battery 520that can be replaceable and/or rechargeable, which in variousconstructions has an approximately three hour life under continuous use.As discussed below, a motion sensor such as sensor 510 can also be usedto obtain feedback from the patient regarding paresthesia.

The processing of the inputs from the sensors 504 and 505 takes place ina controller, such as a microcontroller 525. An exemplarymicrocontroller capable of being used with the invention ismicrocontroller 525, which includes a suitable programmable portion 530(e.g., a microprocessor or a digital signal processor), a memory 535,and a bus 540 or other communication lines. Output data of themicrocontroller 525 is sent via a Bluetooth bi-direction radiocommunication port 545 to the CP (clinician programmer). The Bluetoothportion 545 includes a Bluetooth communication interface, an antennaswitch, and a related antenna, all of which allows wirelesscommunication following the Bluetooth Special Interest Group standard.Other forms of wired and wireless communication between the PFT 500 andother components of the system including the CP are also possible. Otheroutputs may include indicators (such as light-emitting diodes) forcommunicating stimulation activity 550, sensor activation 555, devicepower 560, and battery status 565.

The housing 502 of the PFT 500 may be cylindrical in shape, and in oneparticular construction the cylinder is approximately 35 mm in diameterand 80 mm in length. In other constructions the cylinder is larger orsmaller in diameter and/or length, for example in order to accommodatehands of varying sizes. In various constructions the diameter can rangefrom 20 to 50 mm and the length from 30 to 120 mm, although other sizesabove and below these ranges are also possible.

Furthermore, the shape of the PFT 500 can be other than a circularcross-section, for example oval, square, hexagonal, or other shape.Still further, the cross-section of the PFT 500 can vary along itslength, for example being cylindrical in some portions and oval, square,hexagonal or other shape(s) in other portions. In yet otherconstructions, the PFT 500 has a spherical, toroid, or other shape.

The housing 502 may be made from a resilient material such as rubber orplastic with one or more sensor 505 coupled to or supported by thehousing 502. The manner in which the sensor 505 is coupled to thehousing 502 depends on the type of sensor that is employed, as discussedbelow. Thus, when the patient applies a force to the housing 502, thesensor 505 generates a signal that generally is proportional to thedegree of force applied. Although the discussion herein mentions thepatient using his or her hand to generate force to squeeze the housing502 of the PFT 500, in various constructions the patient may instead useother body parts, such as the mouth or foot, to generate force. Moregenerally, the patient can generate feedback by a physical action,usually a force applied by the hand or other body part, but the physicalaction can include other movements, such as movement of the patient'seyes, head, or hands, to generate a feedback signal.

After the signal is generated, it is transmitted from the sensor 505 tothe controller 525. The controller 525 processes the signal and, basedon one or more such signals from the sensor 505, the controller 525generates another signal that is to be transmitted to the CP. Thecontroller 525 sends the signal to be transmitted to the communicationport 545 of the PFT 500 from which it is then transmitted to the CP orother external device. As discussed further below, the signal can betransmitted from the communication port 545 to the CP using variouswired or wireless methods of communication.

In various constructions, an isotonic force sensor may include a sensorthat measures the distance traveled by the sensor with relativelyconstant force applied by the patient. Isotonic force sensors mayinclude a trigger 570 (See FIG. 10A) or other lever mechanism coupled toa wiper 572 that moves along a rheostat 574 or across a series ofdetectors. Exemplary detectors include electrical contacts or opticaldetectors, such as photodiodes. In other constructions, an isometricforce sensor may include a strain gauge, a piezoelectric device, or apressure sensor, each of which measures force that is proportional tothe pressure applied to the PFT 500 by the patient, generally with onlya small amount of travel or shape change to the sensor.

Both the isotonic and isometric sensors generate an electrical signalthat is proportional to the force that is applied to the sensor. Anisometric force sensor may be incorporated into a relatively stiffobject such that only slight deformation of the object is needed toregister a change in force. In still other constructions, the forcesensor may include a combination of elements, such as a trigger or otherlever that experiences increasing resistance or pressure as the traveldistance increases. For example, increasing resistance or pressure canbe created by attaching a relatively stiff spring to the lever or wipermechanism to increase resistance as the lever or wiper is moved.

In some constructions (e.g. as shown in FIG. 10B), the PFT 500 includesa feedback mechanism 580 that indicates to the patient the amount offorce that is detected by the force sensor 505. The feedback mechanism580 may include one or more of a visual, audible, or tactile feedbackmechanism that is used to indicate to the patient the degree to whichthe sensor 505 has been activated, e.g., how much force has been appliedor how much the lever or wiper mechanism has traveled. The feedbackmechanism gives the patient a sense of whether their activation of thesensor 505 is being detected at what the patient feels is the correctlevel and to give the patient a means to make their activation of thesensor 505 more consistent.

Visual feedback mechanisms 580 can include a series of lights (e.g.LEDs) or a digital readout (e.g. a numerical display); audible feedbackcan include sounds that vary in amplitude (volume) and/or tone; andtactile feedback mechanisms can include vibration of the PFT 500 and/oraltering the shape of the surface of the PFT 500 (e.g. raising of one ormore structures such as dots to form Braille-type patterns) in alocation that is capable of contacting the patient's skin. Using acombination of feedback modalities will benefit patients who havesensory impairments, including, e.g., impaired hearing and/or sight.

The feedback can include a semi-quantitative indication of the patient'sresponse, e.g. including a variety of (e.g. 1-5 or 1-10) intensitylevels to indicate a relative degree of force applied by the patient.The patient will then be able to see, hear, and/or feel the level offorce that is sensed by the sensor 505 of the PFT 500, to help thepatient confirm that their response to the stimulus was received, aswell as the degree of response that was registered. The correlationbetween the level of force applied and the output of the feedbackmechanism 580 can be calibrated separately for each patient during aninitial calibration session.

To facilitate gripping of the PFT 500, the housing 502, in certainconstructions, may be covered with one or more surfaces, textures, ormaterials to improve grip, such as grooves, stipples, indentations,rubber, or plastic, and may include a wrist strap 582 to keep the PFT500 from falling if it is dropped by the patient.

The PFT 500, in some constructions, may also include a connectionfeedback mechanism, particularly where the PFT 500 is in wirelesscommunication with the CP. The connection feedback mechanism can includeone or more of a visual, audible, or tactile mechanism to inform thepatient and/or medical personnel of whether the PFT 500 is maintaining aconnection with the CP, the strength of the connection, and/or if theconnection has been lost. For example, the PFT 500 may emit a signal(e.g. light, sound, and/or tactile) at regular (e.g. one minute)intervals to confirm that communication is still maintained.

Conversely, the PFT 500 may emit such a signal only if communication islost. In some constructions, the PFT 500 may tolerate brief intervals inwhich the signal is lost (e.g. a predetermined time, generally between0.1-100 sec) before the patient is warned of a possible lost connection.In various constructions, the controller 525 of the PFT 500 includesmemory that permits buffering of a limited amount of data, which can beused to accumulate data prior to sending to the CP and which can holddata during brief intervals in which the connection is lost. In variousconstructions, if communication between the PFT 500 and the CP is lostfor more than a predetermined interval of time, then the CP stopsstimulation of electrodes until a connection with the PFT 500 isreestablished.

Thus, according to various constructions, the PFT 500 may include one ormore of: a sound generating mechanism 584 (e.g. a speaker); a tactilemechanism 586 such as a vibration device and/or a mechanism for creatinga raised pattern; a digital numerical readout 588 (e.g. LED or LCDdisplay); and one or more indicator lights 590 (e.g. a series of LEDs);which may be employed to provide feedback to the patient regarding theforce being applied and/or communication status.

Various types of sensing mechanisms can be used for the sensor 505,which would depend in part on the type of housing 502 that is used withthe PFT 500. For example, if the housing 502 is a sealed, flexiblecompartment (e.g. a ball or other object filled with gel, air, orliquid) a piezoelectric-based pressure sensing mechanism can be used asthe sensor 505 in order to measure changes in pressure when the patientsqueezes or relaxes his/her grip on the PFT 500. Alternatively, arheostat 574 or other linear sensing mechanism can be used with a pistolgrip style PFT 500 design (FIG. 10A), where a trigger 570 is coupled toa wiper 572 that moves across the rheostat 574 or other linear sensor.

FIGS. 11A-11C illustrate other embodiments of the PFT for receivingpatient feedback. More specifically, FIG. 11A shows a mouth-piece 620that is inserted into the mouth of the patient. The user providesfeedback by biting the mouthpiece. FIG. 11B shows an optical sensor 630(such as a camera and related image processing software) that detectsvisual cues from a patient. An example visual cue may be the blinking ofthe patient's eyes. FIG. 11C shows a foot pedal 640 that receives inputthrough the patient's manipulation of a switch and/or sensor with hisfoot. In some constructions, the PFT 500 includes one or moreaccelerometers (such as the motion sensor 510), and the patient providesfeedback by moving the PFT 500 in various distinct patterns that arerecognized by the controller 525 of the PFT 500 or by the CP.

It is also envisioned that the patient may provide feedback directly tothe CP. In various constructions, the patient is trained to use theparticular feedback device (e.g. the PFT 500 or the CP as applicable) inorder to properly inform the CP of the patient's reaction to stimuli asthey are applied to the IPG in the patient. In particular constructions,the CP is programmed to learn the patient's response times and/or themagnitude of the patient's responses in order to obtain a profile of thepatient's reaction to various stimuli, as discussed above.

Referring now to FIG. 12, a simplified block diagram of a medicalinfrastructure 800 (which may also be considered a medical system) isillustrated according to various aspects of the present disclosure. Themedical infrastructure 800 includes a plurality of medical devices 810.These medical devices 810 may each be a programmable medical device (orparts thereof) that can deliver a medical therapy to a patient. In someembodiments, the medical devices 810 may include a device of theneurostimulator system discussed above. For example, the medical devices810 may be a pulse generator (e.g., the IPG discussed above), animplantable lead, a charger, or portions thereof. It is understood thateach of the medical devices 810 may be a different type of medicaldevice. In other words, the medical devices 810 need not be the sametype of medical device.

The medical infrastructure 800 also includes a plurality of electronicprogrammers 820. For sake of illustration, one of these electronicprogrammers 820A is illustrated in more detail and discussed in detailbelow. Nevertheless, it is understood that each of the electronicprogrammers 820 may be implemented similar to the electronic programmer820A.

In some embodiments, the electronic programmer 820A may be a clinicianprogrammer, for example the clinician programmer discussed above withreference to FIGS. 2B and 7. In other embodiments, the electronicprogrammer 820A may be a patient programmer discussed above withreference to FIGS. 2B-6. In further embodiments, it is understood thatthe electronic programmer may be a tablet computer. In any case, theelectronic programmer 820A is configured to program the stimulationparameters of the medical devices 810 so that a desired medical therapycan be delivered to a patient.

The electronic programmer 820A contains a communications component 830that is configured to conduct electronic communications with externaldevices. For example, the communications device 830 may include atransceiver. The transceiver contains various electronic circuitrycomponents configured to conduct telecommunications with one or moreexternal devices. The electronic circuitry components allow thetransceiver to conduct telecommunications in one or more of the wired orwireless telecommunications protocols, including communicationsprotocols such as IEEE 802.11 (Wi-Fi), IEEE 802.15 (Bluetooth), GSM,CDMA, LTE, WIMAX, DLNA, HDMI, Medical Implant Communication Service(MICS), etc. In some embodiments, the transceiver includes antennas,filters, switches, various kinds of amplifiers such as low-noiseamplifiers or power amplifiers, digital-to-analog (DAC) converters,analog-to-digital (ADC) converters, mixers, multiplexers anddemultiplexers, oscillators, and/or phase-locked loops (PLLs). Some ofthese electronic circuitry components may be integrated into a singlediscrete device or an integrated circuit (IC) chip.

The electronic programmer 820A contains a touchscreen component 840. Thetouchscreen component 840 may display a touch-sensitive graphical userinterface that is responsive to gesture-based user interactions. Thetouch-sensitive graphical user interface may detect a touch or amovement of a user's finger(s) on the touchscreen and interpret theseuser actions accordingly to perform appropriate tasks. The graphicaluser interface may also utilize a virtual keyboard to receive userinput. In some embodiments, the touch-sensitive screen may be acapacitive touchscreen. In other embodiments, the touch-sensitive screenmay be a resistive touchscreen.

It is understood that the electronic programmer 820A may optionallyinclude additional user input/output components that work in conjunctionwith the touchscreen component 840 to carry out communications with auser. For example, these additional user input/output components mayinclude physical and/or virtual buttons (such as power and volumebuttons) on or off the touch-sensitive screen, physical and/or virtualkeyboards, mouse, track balls, speakers, microphones, light-sensors,light-emitting diodes (LEDs), communications ports (such as USB or HDMIports), joy-sticks, etc.

The electronic programmer 820A contains an imaging component 850. Theimaging component 850 is configured to capture an image of a targetdevice via a scan. For example, the imaging component 850 may be acamera in some embodiments. The camera may be integrated into theelectronic programmer 820A. The camera can be used to take a picture ofa medical device, or scan a visual code of the medical device, forexample its barcode or Quick Response (QR) code.

The electronic programmer contains a memory storage component 860. Thememory storage component 860 may include system memory, (e.g., RAM),static storage (e.g., ROM), or a disk drive (e.g., magnetic or optical),or any other suitable types of computer readable storage media. Forexample, some common types of computer readable media may include floppydisk, flexible disk, hard disk, magnetic tape, any other magneticmedium, CD-ROM, any other optical medium, RAM, PROM, EPROM, FLASH-EPROM,any other memory chip or cartridge, or any other medium from which acomputer is adapted to read. The computer readable medium may include,but is not limited to, non-volatile media and volatile media. Thecomputer readable medium is tangible, concrete, and non-transitory.Logic (for example in the form of computer software code or computerinstructions) may be encoded in such computer readable medium. In someembodiments, the memory storage component 860 (or a portion thereof) maybe configured as a local database capable of storing electronic recordsof medical devices and/or their associated patients.

The electronic programmer contains a processor component 870. Theprocessor component 870 may include a central processing unit (CPU), agraphics processing unit (GPU) a micro-controller, a digital signalprocessor (DSP), or another suitable electronic processor capable ofhandling and executing instructions. In various embodiments, theprocessor component 870 may be implemented using various digital circuitblocks (including logic gates such as AND, OR, NAND, NOR, XOR gates,etc.) along with certain software code. In some embodiments, theprocessor component 870 may execute one or more sequences computerinstructions contained in the memory storage component 860 to performcertain tasks.

It is understood that hard-wired circuitry may be used in place of (orin combination with) software instructions to implement various aspectsof the present disclosure. Where applicable, various embodimentsprovided by the present disclosure may be implemented using hardware,software, or combinations of hardware and software. Also, whereapplicable, the various hardware components and/or software componentsset forth herein may be combined into composite components comprisingsoftware, hardware, and/or both without departing from the spirit of thepresent disclosure. Where applicable, the various hardware componentsand/or software components set forth herein may be separated intosub-components comprising software, hardware, or both without departingfrom the scope of the present disclosure. In addition, where applicable,it is contemplated that software components may be implemented ashardware components and vice-versa.

It is also understood that the electronic programmer 820A is notnecessarily limited to the components 830-870 discussed above, but itmay further include additional components that are used to carry out theprogramming tasks. These additional components are not discussed hereinfor reasons of simplicity. It is also understood that the medicalinfrastructure 800 may include a plurality of electronic programmerssimilar to the electronic programmer 820A discussed herein, but they arenot illustrated in FIG. 12 for reasons of simplicity.

The medical infrastructure 800 also includes an institutional computersystem 890. The institutional computer system 890 is coupled to theelectronic programmer 820A. In some embodiments, the institutionalcomputer system 890 is a computer system of a healthcare institution,for example a hospital. The institutional computer system 890 mayinclude one or more computer servers and/or client terminals that mayeach include the necessary computer hardware and software for conductingelectronic communications and performing programmed tasks. In variousembodiments, the institutional computer system 890 may includecommunications devices (e.g., transceivers), user input/output devices,memory storage devices, and computer processor devices that may sharesimilar properties with the various components 830-870 of the electronicprogrammer 820A discussed above. For example, the institutional computersystem 890 may include computer servers that are capable ofelectronically communicating with the electronic programmer 820A throughthe MICS protocol or another suitable networking protocol.

The medical infrastructure 800 includes a database 900. In variousembodiments, the database 900 is a remote database—that is, locatedremotely to the institutional computer system 890 and/or the electronicprogrammer 820A. The database 900 is electronically or communicatively(for example through the Internet) coupled to the institutional computersystem 890 and/or the electronic programmer. In some embodiments, thedatabase 900, the institutional computer system 890, and the electronicprogrammer 820A are parts of a cloud-based architecture. In that regard,the database 900 may include cloud-based resources such as mass storagecomputer servers with adequate memory resources to handle requests froma variety of clients. The institutional computer system 890 and theelectronic programmer 820A (or their respective users) may both beconsidered clients of the database 900. In certain embodiments, thefunctionality between the cloud-based resources and its clients may bedivided up in any appropriate manner. For example, the electronicprogrammer 820A may perform basic input/output interactions with a user,but a majority of the processing and caching may be performed by thecloud-based resources in the database 900. However, other divisions ofresponsibility are also possible in various embodiments.

According to the various aspects of the present disclosure, varioustypes of data may be uploaded from the electronic programmer 820A to thedatabase 900. The data saved in the database 900 may thereafter bedownloaded by any of the other electronic programmers 820B-820Ncommunicatively coupled to it, assuming the user of these programmershas the right login permissions.

The database 900 may also include a manufacturer's database in someembodiments. It may be configured to manage an electronic medical deviceinventory, monitor manufacturing of medical devices, control shipping ofmedical devices, and communicate with existing or potential buyers (suchas a healthcare institution). For example, communication with the buyermay include buying and usage history of medical devices and creation ofpurchase orders. A message can be automatically generated when a client(for example a hospital) is projected to run out of equipment, based onthe medical device usage trend analysis done by the database. Accordingto various aspects of the present disclosure, the database 900 is ableto provide these functionalities at least in part via communication withthe electronic programmer 820A and in response to the data sent by theelectronic programmer 820A. These functionalities of the database 900and its communications with the electronic programmer 820A will bediscussed in greater detail later.

The medical infrastructure 800 further includes a manufacturer computersystem 910. The manufacturer computer system 910 is also electronicallyor communicatively (for example through the Internet) coupled to thedatabase 900. Hence, the manufacturer computer system 910 may also beconsidered a part of the cloud architecture. The computer system 910 isa computer system of medical device manufacturer, for example amanufacturer of the medical devices 810 and/or the electronic programmer820A.

In various embodiments, the manufacturer computer system 910 may includeone or more computer servers and/or client terminals that each includesthe necessary computer hardware and software for conducting electroniccommunications and performing programmed tasks. In various embodiments,the manufacturer computer system 910 may include communications devices(e.g., transceivers), user input/output devices, memory storage devices,and computer processor devices that may share similar properties withthe various components 830-870 of the electronic programmer 820Adiscussed above. Since both the manufacturer computer system 910 and theelectronic programmer 820A are coupled to the database 900, themanufacturer computer system 910 and the electronic programmer 820A canconduct electronic communication with each other.

FIG. 13 is a diagrammatic view of a system 1000 of evaluating anefficacy of a sacral nerve stimulation therapy for a patient. Adiagnostic tool, such as a Percutaneous Nerve Evaluation (PNE) needle1010, is inserted through the foramen to stimulate the sacral nerve of apatient. The part of the PNE needle 1010 that is outside the body of thepatient is connected to a coupling mechanism such as a banana clip 1020or an alligator clip. The banana clip 1020 is electrically connected toa trial connector 1030, which is then connected to a trial stimulator1040/external pulse generator. The trial stimulator 1040 generateselectrical pulses as a part of stimulation therapy to stimulate thesacral nerve. With the results of the sacral nerve stimulation, ahealthcare professional can evaluate the efficacy of the sacral nervestimulation therapy based on the location of the PNE needle.

The efficacy of the sacral nerve stimulation therapy is largelydependent on the placement of the PNE needle 1010, i.e., the exactlocation where the electrical stimulation current is delivered. In someembodiments, how well the PNE needle 1010 is placed may correspond tothe patient's muscle contractions in response to the stimulation. Forexample, if the patient exhibits a “bellows or toes” response as aresult of the stimulation current being applied, the PNE needle 1010 isconsidered to have been placed at an optimal location. A bellowsresponse may correspond to the patient feeling a sensation in his/herbellows area, and a toes response may correspond to the patient feelinga sensation in his/her toes. In some cases, the bellows response mayinclude a contraction in the anal region of the patient, and the toesresponse may include an involuntary movement of the toes of the patient.The order of the responses also matters. For example, it is desirable tohave a bellows response before a toes response. A more detaileddiscussion of the “bellows and toes” response is found in U.S. patentapplication Ser. No. 14/537,293, filed on Nov. 12, 2014, and entitled“IPG CONFIGURED TO DELIVER DIFFERENT PULSE REGIMES TO DIFFERENT LEADS”to Kaula et. al., the disclosure of which is hereby incorporated byreference in its entirety.

When the electrical stimulation is applied at low frequency, for exampleless than a few pulses per second, it is relatively easy for thehealthcare professional to visually observe the muscle contractions(e.g., the bellows and toes responses). However, as the stimulationfrequency increases, for example above 12 or 15 pulses per second, thepatient's muscle contractions may speed up too fast to the point that itmay appear as a single contraction to the healthcare professional,rather than one or more distinct individual muscle contractions. In thatcase, the healthcare professional cannot accurately determine what ledto the muscle contractions, or he might miss the contraction altogether.For example, if the healthcare professional is moving the PNE needle1010 to determine optimal needle placement while stimulation is turnedon, then a fast stimulation pulse frequency (e.g., greater than 12 or 15pulses per second) may obscure this determination, since the healthcareprofessional may no longer be able to observe distinct musclecontractions from the patient that would clearly correlate to differentneedle positions.

Thus, to avoid this problem, many healthcare professionals elect to usethe banana clip 1020 in the system shown in FIG. 13 discussed above tomanually establish and cut off an electrical connection between thetrial stimulator 1040 (the device that is generating the stimulationpulses) and the PNE needle 1010. Using the banana clip 1020, thehealthcare professional may either clip or unclip the PNE needle 1010.When the PNE needle 1010 is clipped (or otherwise connected) to thebanana clip 1020, an electrical connection is established between thePNE needle 1010 and the trial stimulator 1040. When the PNE needle 1010is unclipped (or otherwise disconnected) from the banana clip 1020, theelectrical connection between the PNE needle 1010 and the trialstimulator 1040 is cut off. Thus, by clipping and unclipping the bananaclip 1020 to and from the PNE needle 1010, the healthcare professionalmay control when the electrical stimulation pulse is on, so that he canattempt to observe the patient's muscle contractions.

For example, with the stimulation off (banana clip 1020 being unclippedfrom the PNE needle 1010), the healthcare professional may position thePNE needle 1010 in one area. The healthcare professional may then clipthe banana clip 1020 to the PNE needle 1010, thereby turning stimulationon. At this point, the healthcare professional may try to observe anymuscle contractions from the patient, such as bellows or toes responses,and based on the presence or absence of the patient's musclecontractions, the healthcare professional may make an evaluation on howeffective the current placement of the PNE needle 1010 is inside thepatient's sacrum. The healthcare professional may then turn thestimulation off by unclipping the banana clip 1020 from the PNE needle1010, move the PNE needle 1010 to a different location, clip the bananaclip 1020 back on the PNE needle 1010, and try to observe the patient'smuscle contractions again. This process may be repeated a number oftimes until the healthcare professional has determined that he hasevaluated the different PNE needle 1010 placements to his satisfaction.

However, the above approach may also have shortcomings. For example, thepatient's muscle contractions may be occurring at a different area thatis remote from the area where the banana clip 1020 and the PNE needle1010 are located. For example, the banana clip 1020 and the PNE needle1010 may be located close to the patient's abdomen, but part of themuscle contractions (e.g., bellows and toes) may be coming from thepatient's toes. Therefore, the healthcare professional has to constantlylook to the patient's toes while he is trying to connect and disconnectthe banana clip 1020 to and from the PNE needle 1010. This may bedifficult, as the healthcare professional may not be able to pay fullattention to two areas simultaneously, and if he is not careful, hemight miss an otherwise observable muscle contraction. Alternatively, anassistant to the healthcare professional may be called upon to justmonitor the muscle contractions in the areas where the contractions arelikely to occur, while the healthcare professional only pays attentionto connecting and disconnecting the banana clip 1020 from the PNE needle1010. But this approach is a waste of human resources. Furthermore, theoperator of the electronic programmer may have to be outside of thesterile field, which further limits the operator's observationcapabilities.

The present disclosure overcomes the problem discussed above byelectronically simulating or mimicking the manual act of connecting anddisconnecting the banana clip 1020 to and from the PNE needle 1010.Referring to FIG. 14, a graphical user interface 1100 of an electronicprogrammer is illustrated. The electronic programmer may be anembodiment of the clinician programmer 22 in FIGS. 2B and 7 and isconfigured to program a pulse generator (such as the trial stimulator1040 shown in FIG. 13) via a wireless communication protocol (e.g.,MICS), so as to generate the electrical pulses used to provide thesacral nerve stimulation. The graphical user interface 1100 illustratesa virtual representation of the PNE needle 1010 (hereinafterinterchangeably referred to as the virtual PNE needle 1010), a virtualrepresentation of the trial connector 1030 (hereinafter interchangeablyreferred to as the virtual trial connector 1030), and a virtualrepresentation of the trial stimulator 1040 (hereinafter interchangeablyreferred to as the virtual trial stimulator 1040). In other words, thegraphical user interface 1100 displays a virtual depiction of theelectrical coupling between the PNE needle 1010 and the trial stimulator1040. A user such as the healthcare professional may utilize thegraphical user interface 1100 to establish a simulated electricalconnection between the virtual PNE needle 1010 and the virtual trialstimulator 1040 via the virtual trial connector 1030.

Correspondingly, the healthcare professional may also establish anactual electrical connection between the PNE needle 1010 and the trialstimulator 1040 via the trial connector 1030. In establishing the actualelectrical connection, the healthcare professional may elect to use thebanana clip 1020 discussed above with reference to FIG. 13 or anothersuitable device. However, according to the various aspects of thepresent disclosure, the healthcare professional no longer need toconstantly connect and disconnect the banana clip 1020 to and from thePNE needle 1010. Rather, he may leave the banana clip 1020 (or anothersuitable device) clipped on to the PNE needle 1010 the entire time. Theelectronic programmer herein will then mimic the aforementionedconnecting/disconnecting of the banana clip 1020 electronically byrunning an electrical stimulation pulse for a predetermined period oftime, and then stopping the electrical stimulation pulse for apredetermined period of time. In this manner, the electronic programmersimulates an intermittent (but controlled) electrical coupling between adiagnostic tool such as the PNE needle 1010 and a pulse generator suchas the trial stimulator 1040. However, it is understood that theelectronic programmer is not the only device capable of performing thisintermittent electrical coupling. In some embodiments, the trialstimulator 1040 itself may be used to perform the intermittentelectrical coupling. For example, the trial stimulator 1040 may beimplemented with a physical button or a virtual button that if pressed,will activate or deactivate the simulated electrical coupling discussedabove. Of course, the activation and deactivation of the simulatedelectrical coupling may be accomplished using two separate buttons onthe trial stimulator 1040 as well. As another example, a speciallydesigned lead (replacing the PNE needle 1010 in FIG. 13) may also beused to carry out the intermittent coupling. In embodiments where thetrial stimulator 1040 or the specially designed lead are used to performthe intermittent electrical coupling, the electrical circuitryconfigured to simulate the intermittent coupling may be integrated intothe trial stimulator 1040 and the lead, respectively.

FIG. 17 is an example waveform 1300 that describes the intermittentelectrical coupling between the PNE needle 1010 and the trial stimulator1040 discussed above. The waveform 1300 is obtained by plotting theamplitude of the electrical output of the trial stimulator 1040 (Y-axis)with respect to time (X-axis). The waveform 1300 includes a plurality ofrepeating cycles, where each cycle includes a time period 1310 andfollowed by a time period 1320. In the time period 1310, the electronicprogrammer (e.g., the clinician programmer 22) instructs (e.g., via anestablished MICS telecommunications link) the trial stimulator 1040 togenerate the electrical pulses as a part of the stimulation therapy. Insome embodiments, the electrical pulses may be generated at a frequencythat is faster than 12 or 15 pulses per second, which as discussed abovemay cause the patient's muscle contractions to speed up to the pointthat they cannot be individually discerned by a healthcare professional.

Also for reasons of simplicity, the pulses shown in FIG. 17 may not bedrawn to scale and may not include an accurate depiction of a recoveryor charge-balancing phase. In other words, the time period 1310corresponds to the trial stimulator turning on the generation ofstimulation pulses under the instruction of the electronic programmer,but it does not necessarily mean that the electrical pulses are “on”throughout the entire period 1310. For example, the time period 1310 mayalso include the interphase times between consecutive pulses when nostimulation pulses are “on”, or the passive or active recovery phaseswhen a pulse opposite in amplitude (opposite from the stimulationpulses) are produced for charge balancing purposes.

In the time period 1320, the electronic programmer instructs the trialstimulator 1040 to stop the generation of electrical pulses. In thisperiod 1320, the output of the trial stimulator is zero (orsubstantially close to zero), thereby mimicking an electricaldisconnection between the trial stimulator and the PNE needle.

The cycle that is made up of the time periods 1310 and 1320 repeatscontinuously until the electronic programmer ends the simulation. It canbe seen that the time period 1310 of the cycle mimics the situationwhere an electrical coupling between the trial stimulator 1040 and thePNE needle 1010 exists, whereas the time period 1320 of the cycle mimicsthe situation where the electrical coupling between the trial stimulator1040 and the PNE needle 1010 is cut off. In this manner, the electronicprogrammer and the trial stimulator 1040 simulates a controlledintermittent electrical coupling between a pulse generator such as thetrial stimulator 1040 and a diagnostic tool such as the PNE needle 1010.In other words, the healthcare professional need not manually connectand disconnect the banana clip 1020 to the PNE needle 1010 in thecontext discussed above with reference to FIG. 13, since the electronicprogrammer can now mimic the constant manual connection/disconnection bycontrolling the trial stimulator 1040 to periodically turn on and offits output.

Referring back to FIG. 14, this simulation can be activated ordeactivated by the user engaging with a virtual control mechanism 1400via the graphical user interface 1100. The virtual control mechanism1400 may include a clickable simulation start/stop button 1410. Thegraphical user interface 1100 also provides a “Time ON/OFF” field 1420,where the user can specify the predetermined amount of time that thestimulation is automatically allowed to run, and the predeterminedamount of time that the stimulation is automatically shut off. In theembodiment illustrated in FIG. 14, the predetermined amount of time is 1second, meaning that the stimulation automatically runs for 1 second,and then automatically stops for 1 second, and then resumes again. Inthis manner, the electrical connection between the PNE needle 1010 andthe trial stimulator 1040 is automatically started, stopped, and resumedagain by software on the electronic programmer, rather than manually bythe healthcare professional. As discussed above, this on/off process maybe repeated a number of times. In other embodiments, the graphical userinterface 1100 may be configured to allow the user to specify an Xamount of time for which the stimulation is automatically run, but a Yamount of time for which the stimulation is automatically shut off,where X is different from Y. For example, the user may specify that thestimulation is automatically run for 2 seconds, and then have thestimulation stopped for 3 seconds, before the stimulation is run again.

In any case, since the electronic programmer automatically cyclesbetween a stimulation-on state and a stimulation-off state (therebymimicking the healthcare professional manually clipping and unclippingthe banana clip 1020), the healthcare professional now does not have toconnect and disconnect the electrical connection between the PNE needle1010 and the trial stimulator 1040 manually. This allows the healthcareprofessional to pay his undivided attention to the patient's anticipatedmuscle contraction areas, which increases the accuracy of any perceivedobservation of the patient's muscle contractions and also speeds up theprocedure.

In some embodiments, a feedback mechanism, for example the PFT discussedabove with reference to FIGS. 9-11, is also implemented to notify thehealthcare professional that the stimulation is turned on (measured by asatisfactory stimulation current, not the stimulation voltage). Avirtual representation of the feedback mechanism may also be shown as avirtual PFT 1450 via the graphical user interface 1100 in FIG. 14.

The feedback mechanism may include an audible feedback mechanism, suchthat the electronic programmer plays a “beep” or some other suitablesound when the stimulation is cycled to be on (i.e., simulating thebanana clip 1020 being clipped to the PNE needle 1010), but will remainsilent when the stimulation is cycled to be off, or vice versa. Asanother example, the feedback mechanism may be visual, such thatsuitable graphics or images may be displayed via the graphical userinterface 1100 only when the stimulation is on, or only when thestimulation is off. Alternatively, different suitable graphics or imagesmay be displayed when the stimulation are on and off. As yet anotherexample, the feedback mechanism may be tactile, such that the electronicprogrammer may vibrate or otherwise send its user a tactile responseonly when the stimulation is on, or only when the stimulation is off. Inall these examples, a first feedback signal is communicated to the user(e.g., the healthcare professional) during a first time period (e.g.,the time period 1310 in FIG. 17) when the trial stimulator is instructedto generate electrical stimulation pulses, while a second (anddifferent) feedback signal is communicated to the user during a secondtime period (e.g., the time period 1320 in FIG. 17) when the trialstimulator is instructed to stop generating electrical stimulationpulses. The feedback signal may be audible, visual, or tactile, asdiscussed above.

It is understood that the feedback mechanism need not necessarily beimplemented on the electronic programmer either. For example, in someembodiments, visual or audio feedback may be implemented on or near thebanana clip 1020 to alert the healthcare professional when the trialstimulator is instructed to generate stimulation pulses (i.e., duringthe first time period 1310 in FIG. 17). The visual feedback may includeone or more light-emitting diodes (LEDs) that light up when thestimulation is on.

The graphical user interface 1100 also allows the ramping up of thestimulation current amplitude as the stimulation is automatically cycledon and off. For example, the healthcare professional may specify a stepsize of 0.05 mA and start ramping up the stimulation current amplitudefrom a starting value (e.g., 1 mA) by 0.05 mA at a time. As thestimulation current amplitude is being ramped up, for example bypressing the “+” button of the virtual control mechanism 1400illustrated in FIG. 14, the stimulation current is still turned on andoff automatically by the trial stimulator 1040. If the healthcareprofessional observes a muscle contraction at a particular stimulationcurrent amplitude, he may record it. The automatic on/off cycling of thestimulation pulse helps the healthcare professional determine whetherthe observed patient muscle contraction did actually occur at thatparticular stimulation current amplitude.

Referring now to FIG. 15, the graphical user interface 1100 provides amenu 1500 of common motor and sensory responses the patient may exhibitin response to the stimulation. The motor responses may include foot,heel, leg, bellows, great toe, bottom foot, and other (e.g., the usercan input a custom response). The sensory responses may includegenitals, perineum, tailbone, rectal, low extremity, butt cheek, andother (e.g., a custom response). The healthcare professional may selectone or more of these responses and hit the “submit” button to record theparticular manner the patient has responded to a given set ofstimulation parameters and stimulation location. In another embodiment,the responses from the patient are recorded using an automaticclosed-loop system using evoked potential sensors.

Referring now to FIG. 16, the graphical user interface 1100 alsodisplays a plurality of selectable buttons 1600-1620 to define thepatient's current sedation state. As non-limiting examples, the button1600 indicates that the patient is awake, another button 1610 indicatesthat the patient is sedated, and another button 1620 indicates that thepatient is under general anesthesia. The graphical user interface 1100in FIG. 16 also displays a plurality of selectable virtual contacts 1650(e.g., contacts on a lead). For each of these selected sedation states,the healthcare professional may select one or more contacts and recordthe patient responses (e.g., bellows or butt cheek) exhibited inassociation with that specific contact being activated to deliver thestimulation.

Again, for each of the contacts, the healthcare professional may repeatthe automatic on/off cycling of the stimulation as discussed above tomimic the stimulation current being turned on and off, while slowingramping up the stimulation current amplitude one step size at a time. Itis understood that, one of the reasons the sedation states are recordedin conjunction with patient responses is to determine whether thetherapy has changed over time. The physician may compare currentresponses with those from the ones stored in the electronic programmer.

In the context discussed above in association with FIG. 13, thehealthcare professional may manually connect and disconnect the bananaclip 1020 to and from the PNE needle 1010 in an attempt to establish anelectrical connection and cut off the electrical connection. The variousaspects of the present disclosure discussed above also allows thehealthcare professional to mimic the constant clipping and unclipping ofthe banana clip 1020 by using the electronic programmer to automaticallycycle the stimulation on and off. However, in either of these scenarios,the healthcare professional cannot be fully certain that an actual andhealthy electrical connection has been established.

As such, it is possible that the healthcare professional may believethat an actual healthy electrical connection has been establishedbetween the PNE needle 1010 and the trial stimulator 1040, while inactuality the connection is defective. The defective connection may becaused by poor connection between the trial stimulator 1040 and thetrial connector 1030, or poor connection between the trial connector1030 and the banana clip 1020, or poor connection between the bananaclip 1020 and the PNE needle 1010, or even problems caused by thepatient's body tissue. In any case, the defective connection mayinterfere with the healthcare professional's evaluation of the patient'sresponses to stimulation, because the stimulation current may not beeffectively delivered to the patient in the first place.

To overcome this problem, the present disclosure also provides a visualindication of the electrical connection health of the system discussedherein. For example, referring back to FIG. 14, when the healthcareprofessional first establishes a virtual connection between the virtualPNE needle 1010 and the virtual trial stimulator 1040, the electronicprogrammer runs an impedance test/check to determine the impedance(s)between the PNE and the trial stimulator 1040. The graphical userinterface 1100 displays a connection health indicator 1700 to indicatethe connection health between the PNE needle 1010 and the trialstimulator 1040.

Depending on the result of the impedance check, the connection healthindicator 1700 may be displayed differently, for example with differentcolors. In some embodiments, a green color of the connection healthindicator 1700 means that the actual electrical connection between thePNE needle 1010 and the trial stimulator 1040 is in very good shape(e.g., the impedance between the PNE needle 1010 and the trialstimulator 1040 being within a first impedance range). A yellow color ofthe connection health indicator 1700 means that the connection betweenthe PNE needle 1010 and the trial stimulator 1040 may have been shorted,which is manifested by a low impedance. A red color of the connectionhealth indicator 1700 means that the actual electrical connectionbetween the PNE needle 1010 and the trial stimulator 1040 may be anelectrical open, which is manifested as a high impedance.

Of course, it is understood that the actual connection health may alsobe indicated by other visual means other than color, or even by an audiosignal (e.g., a loud beep when the connection health is bad) or tactilefeedback in some embodiments. In any case, once the healthcareprofessional can be certain that the connection health is actually good,he may proceed to the next step—applying stimulation to the patient andmonitoring the patient's response—with more confidence that theprocedure is being performed correctly, and that observed patientresponse (or the lack thereof) is meaningful.

FIG. 19 is a flowchart illustrating a method 2000 of programmingelectrical stimulation therapy for a patient. In some embodiments, thesteps of the method 2000 are performed by a portable electronic device,for example the clinician programmer discussed above with reference toFIGS. 2B and 7.

The method 2000 includes a step 2010 of establishing a communicationslink with a pulse generator. The pulse generator is configured togenerate electrical stimulation pulses as a part of the electricalstimulation therapy for a patient. In some embodiments, the pulsegenerator is a trial stimulator located outside a body of the patient.

The method 2000 includes a step 2020 of simulating an intermittentelectrical coupling between the pulse generator and a diagnostic tool byinstructing, for a plurality of cycles, the pulse generator toautomatically turn on and off the generation of electrical stimulationpulses. In some embodiments, the diagnostic tool includes a percutaneousnerve evaluation (PNE) needle inserted inside the body of the patient.For the plurality of cycles, each cycle includes a first time period anda second time period following the first time period. The step 2020includes a step of instructing the pulse generator to generate theelectrical stimulation pulses during the first time period. The step2020 also includes a step of instructing the pulse generator to stopgenerating the electrical stimulation pulses during the second timeperiod.

In some embodiments, the method 2000 includes a step 2030 of displaying,via a touch-sensitive graphical user interface, a virtual depiction ofthe electrical coupling between the diagnostic tool and the pulsegenerator.

In some embodiments, the method 2000 includes a step 2040 ofcommunicating a feedback signal to the user to correspond with: thefirst time period in which the electrical stimulation pulses aregenerated; or the second time period in which the electrical stimulationpulses are stopped. In some embodiments, the communicating of thefeedback signal comprises: communicating a first feedback signal to theuser to correspond with the first time period in which the electricalstimulation pulses are generated; and communicating a second feedbacksignal to the user to correspond with the second time period in whichthe electrical stimulation pulses are stopped, the second feedbacksignal being different from the first feedback signal.

In some embodiments, the electrical stimulation pulses are configured tocause one or more muscles of the patient to contract, and the electricalstimulation pulses are generated to have a frequency sufficiently highsuch that resulting muscle contractions from the patient are too fast tobe individually distinguished. In some embodiments, the frequency of theelectrical stimulation pulses is faster than 12 pulses per second.

It is understood that some of the steps 2010-2040 need not necessarilybe performed sequentially unless otherwise specified. It is alsounderstood that the method 2000 may include additional steps may beperformed before, during, or after the steps 2010-2040. For example, themethod 2000 may include a step of receiving definitions for the firsttime period and the second time period from the user via atouch-sensitive graphical user interface.

The foregoing has outlined features of several embodiments so that thoseskilled in the art may better understand the detailed description thatfollows. Those skilled in the art should appreciate that they mayreadily use the present disclosure as a basis for designing or modifyingother processes and structures for carrying out the same purposes and/orachieving the same advantages of the embodiments introduced herein.Those skilled in the art should also realize that such equivalentconstructions do not depart from the spirit and scope of the presentdisclosure, and that they may make various changes, substitutions andalterations herein without departing from the spirit and scope of thepresent disclosure.

What is claimed is:
 1. A portable electronic device for programmingelectrical stimulation therapy for a patient, the portable electronicdevice comprising: a graphical user interface configured to receive aninput from a user who is not the patient and communicate an output tothe user; an electronic memory storage configured to store programminginstructions; and one or more processors configured to execute theprogramming instructions to perform the following steps: establishing acommunications link with a trial stimulator that is configured togenerate electrical stimulation pulses for treating the patient, thetrial stimulator being located external to the patient; simulating anintermittent electrical coupling between the trial stimulator and apercutaneous nerve evaluation (PNE) needle inserted inside a body of thepatient, wherein the simulating comprises: instructing the trialstimulator to automatically turn on and off the generation of electricalstimulation pulses for a plurality of cycles as a stimulation currentamplitude is being ramped up to provide the user with a user detectablephysiological evoked response and a user detectable physiologicalrelaxed response, wherein more than one cycle occurs before thestimulation current amplitude is fully ramped up; and communicating afirst feedback signal and a second feedback signal to the user; wherein:each cycle includes a first time period and a second time periodfollowing the first time period; the simulating comprises instructingthe trial stimulator to generate the electrical stimulation pulsesduring the first time period such that it results in the user detectablephysiological evoked response; the simulating further comprisesinstructing the trial stimulator to stop generating the electricalstimulation pulses during the second time period such that a lack of theelectrical pulses results in the user detectable physiological relaxedresponse; the first feedback signal corresponds with the first timeperiod in which the electrical stimulation pulses are generated; and thesecond feedback signal corresponds with the second time period in whichthe electrical stimulation pulses are stopped, the second feedbacksignal being different from the first feedback signal.
 2. The portableelectronic device of claim 1, wherein the steps further comprise:receiving definitions for the first time period and the second timeperiod from the user via the graphical user interface.
 3. The portableelectronic device of claim 1, wherein the first feedback signal and thesecond feedback signal include visual signals or audio signals.
 4. Theportable electronic device of claim 1, wherein the first time period andthe second time period are each in a range of several seconds.
 5. Theportable electronic device of claim 1, wherein: the electricalstimulation pulses are configured to cause one or more muscles of thepatient to contract; and the electrical stimulation pulses are generatedto have a frequency sufficiently high such that resulting musclecontractions from the patient are too fast to be individuallydistinguished.
 6. The portable electronic device of claim 1, wherein thesteps further comprise: displaying a plurality of user-selectable commonmotor responses and sensory responses the patient may exhibit inresponse to the simulated intermittent electrical coupling between thetrial stimulator and the PNE needle.
 7. The portable electronic deviceof claim 1, wherein the steps further comprise: performing an impedancecheck to determine an impedance value between the PNE needle and thetrial stimulator; and adjusting a visual characteristic of a visualindicator displayed via the graphical user interface based on theimpedance value.
 8. The portable electronic device of claim 7, whereinthe adjusting comprises: displaying the visual indicator with a firstcolor in response to the impedance value falling within a firstimpedance range; and displaying the visual indicator with a second colordifferent from the first color in response to the impedance valuefalling within a second impedance range different from the firstimpedance range.
 9. A medical system, comprising: a trial stimulatorconfigured to generate electrical stimulation pulses as a part of anelectrical stimulation therapy for a patient, the trial stimulator beinglocated external to the patient; a percutaneous nerve evaluation (PNE)needle configured to be inserted percutaneously inside a body of thepatient to deliver the electrical stimulation pulses; and a firstportable electronic device that is coupled to the trial stimulatorthrough a communications link, wherein the first portable electronicdevice is configured to simulate an intermittent electrical couplingbetween the trial stimulator and the PNE needle by: sending instructionsto the trial stimulator to turn on and off the generation of electricalstimulation pulses for a plurality of cycles; as a stimulation currentamplitude is being ramped up, that provide the user with a userdetectable physiological evoked response period and a user detectablephysiological relaxed response period, wherein more than one cycleoccurs before the stimulation current amplitude is fully ramped up; asecond portable electronic device configured to program the trialstimulator; a patient feedback device that is separate from the trialstimulator, the PNE needle, the first portable electronic device, andthe second portable electronic device, wherein the patient feedbackdevice is configured to communicate a first feedback signal and a secondfeedback signal to a user; wherein: each cycle includes a first timeperiod and a second time period following the first time period; thefirst portable electronic device instructs the trial stimulator togenerate the electrical stimulation pulses during the first time period;the first portable electronic device instructs the trial stimulator tostop generating the electrical stimulation pulses during the second timeperiod; the first feedback signal corresponds with the first time periodin which the electrical stimulation pulses are generated; and the secondfeedback signal corresponds with the second time period in which theelectrical stimulation pulses are stopped.
 10. The medical system ofclaim 9, wherein the first portable electronic device is furtherconfigured to receive definitions for the first time period and thesecond time period from the user via a touch-sensitive graphical userinterface, and wherein the patient feedback device lacks a capability toprogram the trial stimulator.
 11. The medical system of claim 9,wherein: the electrical stimulation pulses are configured to cause oneor more muscles of the patient to contract; and the electricalstimulation pulses are generated to have a frequency sufficiently highsuch that resulting muscle contractions from the patient are too fast tobe individually distinguished.
 12. The medical system of claim 9,wherein: turning on and off the generation of the electrical stimulationpulses provide a user with a user detectable physiological evokedresponse from the patient and a detectable physiological relaxedresponse from the patient; the generation of the electrical stimulationpulses during the first time period results in the user detectablephysiological evoked response; and a lack of the electrical stimulationpulses during the second time period results in the user detectablephysiological relaxed response.
 13. A method of programming electricalstimulation therapy for a patient, comprising: maintaining an actual andcontinuous physical and electrical coupling between a trial stimulatorand a percutaneous nerve evaluation (PNE) needle via a trial connector,the trial stimulator being configured to generate electrical stimulationpulses for treating the patient, the trial stimulator being locatedexternal to the patient; simulating, while the actual and continuousphysical and electrical coupling is maintained, an intermittentelectrical coupling between the trial stimulator configured to generateelectrical stimulation pulses and a diagnostic tool by instructing, fora plurality of cycles, the trial stimulator to automatically turn on andoff the generation of electrical stimulation pulses while a stimulationamplitude is being ramped up, wherein each cycle includes a first timeperiod and a second time period following the first time period, andwherein the simulating includes: instructing the trial stimulator togenerate the electrical stimulation pulses during the first time period;and instructing the trial stimulator to stop generating the electricalstimulation pulses during the second time period; and communicating oneor more feedback signals to a user to correspond with: the first timeperiod in which the electrical stimulation pulses are generated; or thesecond time period in which the electrical stimulation pulses arestopped.
 14. The method of claim 13, further comprising: establishing,via an electronic programmer, a communications link with the trialstimulator, wherein the electronic programmer has a touch-sensitivegraphical user interface; and receiving definitions for the first timeperiod and the second time period from the user via the touch-sensitivegraphical user interface.
 15. The method of claim 13, wherein: themaintaining and the simulating are performed using a clinicianprogrammer; and the communicating is performed using the clinicianprogrammer or a patient feedback device that is separate and differentfrom the clinician programmer.
 16. The method of claim 15, wherein thecommunicating of the one or more feedback signals comprises:communicating a first feedback signal to the user to correspond with thefirst time period in which the electrical stimulation pulses aregenerated; and communicating a second feedback signal to the user tocorrespond with the second time period in which the electricalstimulation pulses are stopped, the second feedback signal beingdifferent from the first feedback signal.
 17. The method of claim 13,wherein: the electrical stimulation pulses are configured to cause oneor more muscles of the patient to contract; and the electricalstimulation pulses are generated to have a frequency sufficiently highsuch that resulting muscle contractions from the patient are too fast tobe individually distinguished.
 18. The method of claim 13, wherein:turning on and off the generation of the electrical stimulation pulsesprovide a user with a user detectable physiological evoked response fromthe patient and a detectable physiological relaxed response from thepatient; the generation of the electrical stimulation pulses during thefirst time period results in the user detectable physiological evokedresponse; and a lack of the electrical stimulation pulses during thesecond time period results in the user detectable physiological relaxedresponse.
 19. The method of claim 13, wherein in the first period, thetrial stimulator automatically turns on and off the generation of theelectrical stimulation pulses at a frequency sufficiently fast such thatmuscle contractions of the patient in response to each cycle of theelectrical stimulation pulses become indistinguishable from one another.20. The method of claim 13, further comprising: displaying a pluralityof common motor responses and sensory responses the patient may exhibitin response to the simulated intermittent electrical coupling betweenthe trial stimulator and the PNE needle; and receiving a submission ofone or more of the common motor responses and sensory responses inresponse to user input.